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儿童比阿培南(L-627)的药代动力学、细菌学及临床研究

[Pharmacokinetic, bacteriological and clinical studies on biapenem (L-627) in children].

作者信息

Tajima T, Niimi R, Kobayashi M, Kobayashi-Negishi S, Kondo Y, Nakayama-Esaki E, Nishimura S, Hagiwara N, Abe T

机构信息

Department of Pediatrics, Teikyo University, School of Medicine.

出版信息

Jpn J Antibiot. 1994 Jul;47(7):896-902.

PMID:7933524
Abstract

The results are summarized as follows: 1. A total of 10 patients were treated with biapenem (L-627). We received informed consent from all of their parents. Each dose was 6 mg/kg, and it was administered 3 times daily (40 mg/kg, 4 times daily in meningitis), in a 30-minute intravenous drip infusion for 5-17 days. The clinical efficacies of L-627 in 10 patients with bacterial infections (1 with purulent meningitis, 1 with sepsis, 5 with pneumonia, 2 with urinary tract infection and 1 with purulent tonsillitis) were evaluated as excellent in 8 patients, as good in 2 patients with an efficacy rate of 100%. Seven causative organisms found in 5 patients (Streptococcus pneumoniae in 2, Moraxella (Branhamella) catarrhalis in 2, Haemophilus influenzae in 2 and Pseudomonas aeruginosa in 1) were eradicated. No adverse reaction was observed in any of the 10 patients. 2. Pharmacokinetic studies Peak plasma concentrations of L-627 were 12.5-13.7 micrograms/ml at the dose of 6 mg/kg administered by 30-minute drip infusion. Plasma half-lives of L-627 in the beta-phase averaged 0.72 hour (0.63-0.80 hour). CSF concentration/plasma concentration ratios of L-627 were 1.12/8.16 micrograms/ml (Day 2, 1.17 hours after at dose of 20 mg/kg), 0.88/3.44 micrograms/ml (Day 3, 4.0 hours after at dose of 30 mg/kg) and 0.68/5.12 micrograms/ml (Day 13, 3.0 hours after at dose of 40 mg/kg) administered by 30-minute drip infusion in the child with purulent meningitis (case 1).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

结果总结如下

  1. 共有10例患者接受了比阿培南(L-627)治疗。我们获得了所有患者家长的知情同意。每次剂量为6mg/kg,每日给药3次(脑膜炎患者为40mg/kg,每日4次),静脉滴注30分钟,疗程为5至17天。L-627对10例细菌感染患者(1例化脓性脑膜炎、1例败血症、5例肺炎、2例尿路感染和1例化脓性扁桃体炎)的临床疗效评估为:8例优,2例良,有效率为100%。在5例患者中发现的7种致病菌(2例肺炎链球菌、2例卡他莫拉菌、2例流感嗜血杆菌和1例铜绿假单胞菌)被根除。10例患者均未观察到不良反应。2. 药代动力学研究:通过30分钟滴注给予6mg/kg剂量时,L-627的血浆峰浓度为12.5至13.7μg/ml。L-627在β相的血浆半衰期平均为0.72小时(0.63至0.80小时)。在化脓性脑膜炎患儿(病例1)中,通过30分钟滴注给予L-627,其脑脊液浓度/血浆浓度比值分别为1.12/8.16μg/ml(第2天,20mg/kg剂量后1.17小时)、0.88/3.44μg/ml(第3天,30mg/kg剂量后4.0小时)和0.68/5.12μg/ml(第13天,40mg/kg剂量后3.0小时)。(摘要截选至250字)

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